Microcurrent device (Model: HBR2-1)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. November 5, 2021 Shenzhen DJ Medical Equipment Co., Ltd. % Jet Li Regulation Manager Guangzhou KEDA Biology Technology Co., Ltd. 6F, No.1 TianTai road, Science City, LuoGang District Guangzhou, Guangdong China Re: K211055 Trade/Device Name: Microcurrent device (Model: HBR2-1) Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NFO Dated: October 1, 2021 Received: October 7, 2021 Dear Jet Li: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal {1}------------------------------------------------ statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K211055 Device Name Microcurrent device (Model:HBR2-1) Indications for Use (Describe) The device uses microcurrent electrical to stimulate facial tissues for aesthetic purposes. Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 801 Subpart D) X Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) Summary ## 510k number: K211055 This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92. #### Submitter's Information 1. - Manufacturer Name: Shenzhen DJ Medical Equipment Co., Ltd. - Address: Room 801, Building A, FirstFlag Science & Technology Park, No. 26 Baili Road, Nanwan Street., Longgang District, Shenzhen, Guangdong, China - Tel.: +86-755-8557 3525 - Fax: +86-0871-67263826 - Contact Person: Feiyang Huang - E-mail: info@dimiot.com ## Application Correspondent - Guangzhou KEDA Biological Tech Co., Ltd. - Address: 6F, No.1 TianTairoad, Science City, LuoGang District, GuangZhou City, China ● - Contact Person: Mr. Jet Li ● - Title: Regulation Manager ● - Tel: +86-18588874857 ● - Email: med-il@foxmail.com ● ## 2. Subject DeviceInformation Type of 510(k) submission: Traditional Common Name: Stimulator, Nerve, Transcutaneous, Over-The-Counter Trade Name: Microcurrent device (Model: HBR2-1) Classification Name: Stimulator, Nerve, Transcutaneous Review Panel: Neurology, Physical Medicine Product Code: NFO Regulation Number: 882.5890 Regulation Class: 2 {4}------------------------------------------------ #### 3. Predicate Device Information | Sponsor | TAMA Research<br>Corporation | Li-Tek Electronics<br>Technologies | |-------------------|------------------------------|------------------------------------------------------------------| | Device Name | TAMA BEMS Device | Micro-current Wrinkle<br>Removing Facial Service<br>model EP-400 | | 510(k) Number | K173093 | K162106 | | Product Code | NFO | NFO | | Regulation Number | 882.5890 | 882.5890 | | Regulation Class | 2 | 2 | ## 4. Device Description The Microcurrent device (Model: HBR2-1) is a hand-held, non-sterile, reusable device designed to achieve the cosmetic effect. The device consist of main unit and wireless charging station with undetachable USB cable. The device is supplied by internal rechargeable lithium battery. It can be recharged by external charger through the charging station. The device design with Micro current output stimulation function. The MCU-controlled microcurrent circuit generates a low-frequency microcurrent which will applied in the facial skin to do facial stimulation. In the microcurrent stimulation mode, there is ten levels of output intensity which would be adjusted by the button in the device. The device is only intended for home use. ## 5. Intended Use / Indications for Use The device uses microcurrent electrical to stimulate facial tissues for aesthetic purposes. #### 6. Performance Summary #### The device conforms to the following standards: - IEC 60601-1: 2012 Medical electrical equipment Part 1: General requirements for basic safety and essentialperformance {5}------------------------------------------------ - IEC 60601-1-2:2014, Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral standard: Electromaqnetic Compatibility - Requirements and Tests. - IEC 60601-1-11:2015 Medical Electrical Equipment - Part 1-11: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Requirements For Medical Electrical Equipment And Medical Electrical Systems Used In The Home Healthcare Environment - IEC 60601-2-10: 2016, Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators - ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Test for in vitro cytotoxicity. - ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Test for irritation and skin sensitization. ## Software Verification and Validation Testing Software verification and validation testing were conducted and its documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was determined to beof "moderate" level of concern. ## Usability Testing Usability testing was conducted to demonstrate that the device and its labeling can meet the following requirements: 1) the lay user can self-select themselves as being appropriate users of this device by the external box labeling, 2) the lay user can apply the treatment safely and correctly according to the instructions for use, and 3) the lay user can understand all indications, contraindications, warnings and precautions, and be able to identify whether they are within any contraindicated group; and be able to understand the user manual. ## Clinical Testing Clinical data were not required in this submission to support a finding of substantial equivalence. {6}------------------------------------------------ # 7. Comparison to predicate device and conclusion The technological characteristics, features, specifications, materials, mode of operation, and intended use of the Microcurrent device (Model: HBR2-1) is substantially equivalent to the predicate devices quoted above. The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness. {7}------------------------------------------------ | Elements of<br>Comparison | Subject Device<br>(K211055) | Primary Predicate Device<br>(K173093) | Reference device<br>(K162106) | |-----------------------------------------------|--------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name and<br>Model | Microcurrent device<br>Model: HBR2-1 | TAMA BEMS Device | Micro-current Wrinkle<br>Removing Facial Service,<br>model EP-400 | | Intended Use &<br>Indications for<br>Use | The device uses<br>microcurrent electrical to<br>stimulate facial tissues for<br>aesthetic purposes. | The TAMA BEMS Device uses<br>microcurrent electrical to<br>stimulate facial tissues for<br>aesthetic purposes. | The device is intended for<br>facial stimulation by<br>electrode heads for<br>cosmetic use. The device<br>is also intended for the<br>treatment of periorbital<br>wrinkles with red Light<br>Emitting Diode (LED)<br>head. It is for over-the-<br>counter use. | | Prescription Status | Over-the-Counter Use (OTC)<br>Note: Usability study provided<br>to demonstrate OTC use | Prescription Use (Rx) Only | Over-the-Counter Use<br>(OTC) | | Number of<br>outputs mode | 1 | 4 | 1 | | Number of<br>channels | 1 | 1 | 1 | | Output Intensity<br>Level | 10 | -- | -- | | Stimulated<br>muscles | Face | Face | For micro current<br>stimulation: Face;<br>For Red light: periorbital | | Maximum output<br>voltage | 0.54V@500Ω<br>2.24V @ 2kΩ<br>10.8V @ 10kΩ | ±0.400 @500Ω<br>±1.600 @2 k Ω<br>±8.00 @10k Ω | 1.23V @ 500Ω<br>3.64V @ 2kΩ<br>10.9V @ 10kΩ | | Maximum Output<br>Current | 1.08mA @ 500Ω<br>1.12mA@2kΩ<br>1.08mA@10kΩ | ±0.800 @500 Ω<br>±0.800 @2 k Ω<br>±0.800 @10k Ω | 2.46mA @ 500Ω<br>1.82mA @ 2kΩ<br>1.09mA @ 10kΩ | | Frequency range<br>(Hz) | 8.34Hz | Frequency (Hz) [or Rate (pps)]<br>0.045 - 2560 | 59.3Hz | | Pulse width | 60ms | Pulse Duration (msec) 52.6 - 2400 | 4ms | | Contraction and<br>Relaxation time | Adjustable, due to different modes. | Adjustable, due to different modes. | Adjustable, due to different modes. | | Net Charge, (μC)<br>@ 500 Ω | 0μC @500Ω | 0μC @500Ω | 9.04μC@ 500Ω | | Maximum Current<br>Density (mA/cm²<br>@ 500Ω) | 0.0325 mA/cm² @500Ω | 1.591mA/cm2@500Ω | Bigger electrode head:<br>0.044 mA/cm²@ 500Ω<br>Smaller electrode head:<br>0.42 mA/cm²@ 500Ω | | Maximum pow er<br>Density | 106uW/cm² @500Ω | 318uW/cm2 @500Ω | Bigger electrode head<br>0.014 mW/ cm²@ 500Ω<br>Smaller electrode head<br>0.139 mW/ cm²@ 500Ω | | Timer Range | 10 minutes | 0-30 minutes | 10 minutes | | Additional Features | | | | | Power | Adaptor Output: DC 5V,<br>0.3A | Internal 4.3V<br>rechargeable Lithium<br>Polymer battery | 1200mAh lithium battery | | indication display | pow er on, pow er off,<br>operation mode. | On/Off Display Status,<br>Low Battery,<br>Voltage/Current Level | On/Off Status, Low<br>Battery, Voltage/Current<br>Level | | Dimension | About 180 mm*40mm | 3x5x0.7(in.) | --; | | Weight | 80g | 9.5 ounces | --; | | Housing Materials | ABS | Anodized aluminum 6061 | ABS plastic | | Microprocessor<br>control | Yes | Yes | Yes | | Automatic<br>Overload trip | Yes | Yes | Yes | | Automatic no-load<br>trip | Yes | Yes | Yes | | Automatic shut-off | Yes | Yes | Yes | | User override<br>control | Yes | Yes | Yes | | Environment for<br>operating | Temperature: +18° C ~<br>+40° C<br>Relative humidity: 35 % ~<br>75 % | --; | Temperature: 5 ~ 40° C | | Environment for<br>storage | Temperature: -10° C ~ +55°<br>C<br>Relative humidity: 20 % ~<br>80 % | --; | Temperature: -25 ~70° C<br>Humidity: 10 ~90% RH | | Biocompatibility | All user directly contacting<br>materials are compliance<br>with ISO10993-5 and<br>ISO10993-10 requirements. | All user directly contacting<br>materials are compliance with<br>ISO10993-5 and ISO10993-10<br>requirements. | All user directly contacting<br>materials are compliance<br>with ISO10993-5,<br>ISO10993-10 and IEC<br>62471:2006 requirements. | | Electrical Safety | Comply with IEC 60601-1<br>and IEC 60601-2-10;<br>IEC60601-2-57<br>IEC60601-1-11 | Comply with IEC 60601-1 and<br>IEC 60601-2-10 | Comply with IEC 60601-1<br>and IEC 60601-2-10 | | EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | {8}------------------------------------------------ {9}------------------------------------------------ # Final Conclusion: The subject device "Microcurrent device (Model: HBR2-1)" is Substantial Equivalence to the predicate device.